Study of Environmental Enteropathy and Malnutrition in Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 416
- 试验地点
- 2
- 主要终点
- Nutritional status in children assessed by measuring parameters of growth at 9 months of age
研究概览
简要总结
Environmental Enteropathy (EE) is an acquired sub-clinical inflammatory gut condition in which alterations in intestinal structure, function, and local and systemic immune activation lead to impaired vaccine responses, decreased cognitive potential and undernutrition in low-middle income countries. Approximately half of all global deaths in children aged less than five years are attributable to undernutrition making the study of EE an area of critical priority. However, given the operational limitations and ethical considerations for safely obtaining intestinal biopsies from young children in low resource settings, there have been few detailed investigations of human intestinal tissue in this vulnerable patient group for whom reversal of EE would provide the greatest benefit. EE biomarkers have been studied in different settings but these have not been correlated with the gold standard histopathology confirmation. The Study of Environment Enteropathy and Malnutrition in Pakistan (SEEM Pakistan) is designed to better understand the pathophysiology, predictors, biomarkers, and potential management strategies of EE to inform strategies to eradicate this debilitating pathology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 0-6 months from Matiari, Pakistan with weight for height Z score (WHZ) < -2 at the time of enrollment
- •Children aged 0 to 6 months from Matiari, Pakistan who would be growing normally, with WHZ > 0, to serve as controls
- •Healthy control children under the age of 3 years, who will undergo endoscopy at CCHMC
- •Children under the age of 6 years with newly diagnosed celiac disease per endoscopy at CCHMC
- •Children under the age of 10 years with newly diagnosed Crohn's disease per endoscopy at CCHMC
排除标准
- •For healthy control children < 3 years old undergoing endoscopy at CCHMC, biopsies and diagnoses should not supportive of eosinophilic esophagitis
- •For healthy control children < 3 years old undergoing endoscopy at CCHMC, biopsies and diagnoses should not supportive of celiac disease
- •For healthy control children < 3 years old undergoing endoscopy at CCHMC, biopsies and diagnoses should not supportive of inflammatory bowel disease
- •For healthy control children < 3 years old undergoing endoscopy at CCHMC, children should not have been treated with antibiotics ≤ 4 weeks prior to endoscopy
结局指标
主要结局
Nutritional status in children assessed by measuring parameters of growth at 9 months of age
时间窗: At approximately 9 months after entry into study
Our birth cohort will be assessed for nutritional status by measuring parameters of growth, length, weight and height. These measurements will be calculated as Z scores according to WHO tables and children will be divided into the appropriate categories: Stunting as Length for Age Z-score \< -2 SD (standard deviation), underweight as Weight-for-Age Z-score \< -2 SD and wasting as Weight-for-Length Z-score \< -2 SD, or normal-for-age.
Nutritional status in children assessed by measuring parameters of growth at 3-6 months of age
时间窗: Approximately 3-6 months after entry into study
Our birth cohort will be assessed for nutritional status by measuring parameters of growth, length, weight and height. These measurements will be calculated as Z scores according to WHO tables and children will be divided into the appropriate categories: Stunting as Length for Age Z-score \< -2 SD (standard deviation), underweight as Weight-for-Age Z-score \< -2 SD and wasting as Weight-for-Length Z-score \< -2 SD, or normal-for-age.
Association of biomarkers with Environmental Enteropathy at 3-6 months of age
时间窗: Approximately 3-6 months after entry into study
Serum, stool, and urine biomarkers of EE will be collected and tested in malnourished and well-nourished children
Association of biomarkers with Environmental Enteropathy at the time of endoscopy and biopsy
时间窗: At approximately 15 months after entry into study
Serum, stool, and urine biomarkers of EE will be collected and tested in those children who are eligible to undergo upper GI endoscopy and biopsy
The use of UGI biopsy tissue for histopathological and multiomic workup for validation of biomarkers associated with EE
时间窗: At approximately 15 months after entry into study
Biopsy specimens from UGI endoscopy obtained from eligible children will be used for detailed histopathologic and multiomic work up to study the pathophysiology of EE, validate current biomarkers, and generate novel biomarker candidates
Association of biomarkers with Environmental Enteropathy at 9 months of age
时间窗: At approximately 9 months after entry into study
Serum, stool, and urine biomarkers of EE will be collected and tested in malnourished and well-nourished children
次要结局
未报告次要终点
研究者
Dr Syed Asad Ali
Associate Professor, Department of Pediatrics and Child Health
Aga Khan University